PORTEX? BIVONA? ADULT TTS? TRACHEOSTOMY TUBES 670170

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for PORTEX? BIVONA? ADULT TTS? TRACHEOSTOMY TUBES 670170 manufactured by Smiths Medical Asd; Inc..

Event Text Entries

[185923018] Information was received indicating that a smiths medical portex? Bivona? Adult tts? Tracheostomy tube was changed out due to a hole in the balloon. There were no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02648
MDR Report Key9908292
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-01-02
Date Mfgr Received2020-03-02
Device Manufacturer Date2017-09-11
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE N
Manufacturer CityMINNEAPOLIS,, MN
Manufacturer CountryUS
Manufacturer Phone3833310
Manufacturer G1SMITHS MEDICAL ASD; INC.
Manufacturer Street6000 NATHAN LANE N
Manufacturer CityMINNEAPOLIS,, MN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePORTEX? BIVONA? ADULT TTS? TRACHEOSTOMY TUBES
Generic NameTUBE TRACHEOSTOMY AND TUBE CUFF
Product CodeJOH
Date Received2020-03-31
Model Number670170
Catalog Number670170
Lot Number3488067
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD; INC.
Manufacturer Address6000 NATHAN LANE N MINNEAPOLIS,, MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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